Milligard® Cartridge Filters
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概述
规格
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种类
Description
Milligard cartridge filters provide the finest prefiltration available. Milligard filters are constructed of homogeneous polymers of cellulose esters on a polyester web resulting in a versatile filter with high reproducibility and efficacy due to the highly retentive, non-fiber releasing membrane. The homogenous cellulose ester membrane provides the high retention needed during critical prefiltration steps while protecting more expensive downstream filtration devices from premature plugging.
Milligard filters are available in single and double layer formats, as well as a special low protein binding version constructed of low protein binding cellulose esters that is designed for the removal of particles and microorganisms in applications where maximizing protein recovery is critical.
Milligard cartridge filters provide high throughput with minimal differential pressure. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles. Milligard cartridge filters are integrity tested during the manufacturing process.
Regulatory Compliance
Milligard cartridge filters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9000 Quality Systems Standard and are shipped with a Certificate of Quality. Each cartridge filter is supported by a Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each filter is marked with identifying characteristics.
Multiple Format
A full range of filtration areas is available to suit varying application requirements. A variety of connection options are offered for easy adaptation to existing housings.
Typical Applications
Cell Culture Media
Effectively remove particles and colloidal contaminants without obstructing the flow of vital media constituents. Milligard prefilters provide the high flow rates and consistently high throughput required to accomplish the separation in a timely and cost-effective manner.
Final Aseptic Fill of Small Volume Parenterals (SVP)
Extend the service life of downstream sterilizing filters by removing colloidal and particulate contaminants.
Large Volume Parenterals (LVP)
Extend the service life of downstream sterilizing filters by removing colloidal and particulate contaminants. Extremely robust and able to withstand high operating pressures, Milligard filters offer dependable retention and high flow rates needed for high volume manufacturing.
Plasma Proteins—Human Albumin
Remove colloids, aggregated and non-product proteins, lipids and particles prior to downstream purification without retaining the fractions of interest. Milligard filters provide superior protection of downstream sterile filters and/or chromatography columns.
Serum
Effectively remove lipids, colloids, and particles from serum before the final sterilizing filtration without obstructing the passage of serum proteins. Milligard filters provide high flow rates and consistently high throughput.
| Per 10-inch Cartridge | ||
| Filtration Area | ||
| Single Layer | 0.8 m² | |
| Double Layer | 0.69 m² | |
| Materials of Construction | ||
| Chemistry | Mixed Cellulose Esters (MCE) | |
| Support Material | Polyester | |
| Device Material | Polypropylene | |
| Seal Material | Silicone (SI) | |
| Maximum Differential Pressure, bar (psid) | 3.5 bar (50 psid) @ 25 °C | |
| Gravimetric Extractables | ||
| Standard Milligard® Media | The extractables level was equal to or less than 50 mg per 10-inch cartridge after 24 hours in water at controlled room temperature. | |
| Low Protein Binding Milligard® Media | The extractables level was equal to or less than 100 mg per 10-inch cartridge after a 5 L flush and 24 hours in water at controlled room temperature. | |
| Low Protein Binding Milligard® Media | The extractables level was equal to or less than 100 mg per 10-inch cartridge after a 5 L flush and 24 hours in water at controlled room temperature. | |
| Low Protein Binding Milligard® Media | The extractables level was equal to or less than 250 mg per 10-inch cartridge after a 5 L flush and 24 hours in water at controlled room temperature. | |
| Low Protein Binding Milligard® Media | The extractables level was equal to or less than 200 mg per 10-inch cartridge after a 5 L flush and 24 hours in water at controlled room temperature. | |
| Low Protein Binding Milligard® Media | The extractables level was equal to or less than 350 mg per 10-inch cartridge after a 5 L flush and 24 hours in water at controlled room temperature. | |
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L | |
| Sterilization | 10 autoclave cycles or SIP @ 121 °C for 30 min | |
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | |
| Non-Fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). | |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | |
Typical Clean Water Flow Rate vs Pressure Drop
Cartridge Legends Refer to Pore Size (nominal):
Milligard Media
CW03 = 0.2 µm
CW06 = 0.5 µm
CW19 = 1.2 µm
CWSC = 1.2/0.5 µm
CWSS = 0.5/0.2 µm
Milligard LPB Media
CWL3 = 0.2 µm
CWL6 = 0.5 µm
CWL9 = 1.2 µm
CWLC = 1.2/0.5 µm
CWLS = 0.5/0.2 µm
Cartridges with Milligard Media - 30-inch, Cartridge Code 0
Cartridge with Milligard LPB Media - 30-inch, Cartridge Code 0